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TPLC
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Device
transducer, pressure, catheter tip
Product Code
DXO
Regulation Number
870.2870
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACIST MEDICAL SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
EDWARDS LIFECIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC.
SUBSTANTIALLY EQUIVALENT
2
MILLAR INSTRUMENTS, INC.
SUBSTANTIALLY EQUIVALENT
2
MILLAR, INC.
SUBSTANTIALLY EQUIVALENT
1
OPSENS INC
SUBSTANTIALLY EQUIVALENT
2
OPSENS INC.
SUBSTANTIALLY EQUIVALENT
2
ST. JUDE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL (NOW PART OF ABBOTT MEDICAL)
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL SYSTEMS AB
SUBSTANTIALLY EQUIVALENT
2
ZURICH MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
85
85
2015
114
114
2016
152
152
2017
186
186
2018
179
179
2019
153
153
2020
158
158
2021
116
116
2022
144
144
2023
194
194
2024
80
80
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
307
307
Detachment of Device or Device Component
201
201
Fracture
101
101
Break
97
97
Detachment Of Device Component
90
90
Communication or Transmission Problem
87
87
Adverse Event Without Identified Device or Use Problem
77
77
Material Separation
71
71
Device Contamination with Chemical or Other Material
68
68
Incorrect Measurement
64
64
Leak/Splash
55
55
Contamination
54
54
Material Fragmentation
49
49
Failure to Advance
45
45
Difficult to Remove
43
43
Fluid/Blood Leak
33
33
Failure to Zero
25
25
Particulates
25
25
Improper or Incorrect Procedure or Method
23
23
Contamination /Decontamination Problem
22
22
Material Deformation
21
21
Use of Device Problem
21
21
Entrapment of Device
20
20
Device Operates Differently Than Expected
20
20
Difficult to Advance
19
19
Disconnection
19
19
Deformation Due to Compressive Stress
15
15
Material Integrity Problem
15
15
Appropriate Term/Code Not Available
15
15
Physical Resistance/Sticking
13
13
Material Split, Cut or Torn
12
12
Device Handling Problem
11
11
Pressure Problem
11
11
Peeled/Delaminated
11
11
Loose or Intermittent Connection
11
11
Inaccurate Flow Rate
10
10
Kinked
10
10
Unsealed Device Packaging
10
10
Output Problem
9
9
Mechanical Jam
8
8
Device Contaminated During Manufacture or Shipping
8
8
Device Displays Incorrect Message
8
8
Connection Problem
8
8
Stretched
8
8
Sticking
7
7
Crack
7
7
Positioning Problem
7
7
Material Twisted/Bent
7
7
Insufficient Information
6
6
Defective Device
6
6
Calibration Problem
6
6
High Readings
6
6
Display or Visual Feedback Problem
6
6
Mechanical Problem
6
6
Defective Component
6
6
Excess Flow or Over-Infusion
5
5
Incorrect Or Inadequate Test Results
5
5
Air/Gas in Device
5
5
Infusion or Flow Problem
5
5
Failure to Clean Adequately
4
4
Tear, Rip or Hole in Device Packaging
4
4
No Device Output
4
4
Device Damaged Prior to Use
4
4
Difficult to Flush
4
4
Device Alarm System
4
4
Bent
3
3
Complete Blockage
3
3
Flushing Problem
3
3
Material Frayed
3
3
Difficult to Insert
3
3
Difficult To Position
3
3
Obstruction of Flow
3
3
High Test Results
3
3
Physical Resistance
3
3
Contamination of Device Ingredient or Reagent
3
3
Inaccurate Information
3
3
Improper Flow or Infusion
3
3
Device Sensing Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Delamination
2
2
Gas/Air Leak
2
2
Device Dislodged or Dislocated
2
2
Low Test Results
2
2
Low Readings
2
2
Expiration Date Error
2
2
Failure to Disconnect
2
2
Device Difficult to Setup or Prepare
2
2
Decrease in Pressure
2
2
Increase in Pressure
2
2
Off-Label Use
2
2
Unable to Obtain Readings
2
2
Pacing Problem
2
2
Device Inoperable
2
2
No Display/Image
2
2
Migration or Expulsion of Device
2
2
Material Discolored
2
2
Thermal Decomposition of Device
2
2
Backflow
1
1
Difficult or Delayed Positioning
1
1
Component Falling
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
551
551
No Clinical Signs, Symptoms or Conditions
428
428
No Known Impact Or Consequence To Patient
366
366
Device Embedded In Tissue or Plaque
71
71
Vascular Dissection
39
39
No Patient Involvement
36
36
No Code Available
23
23
No Information
22
22
Insufficient Information
21
21
Blood Loss
18
18
Hemorrhage/Bleeding
18
18
Air Embolism
17
17
Cerebrospinal Fluid Leakage
13
13
Foreign Body In Patient
13
13
Death
10
10
Low Blood Pressure/ Hypotension
10
10
Intimal Dissection
9
9
Burn(s)
8
8
Loss of consciousness
8
8
Pericardial Effusion
6
6
Thrombosis
6
6
Unspecified Infection
4
4
High Blood Pressure/ Hypertension
4
4
Injury
3
3
Vasoconstriction
3
3
Chest Pain
3
3
Vessel Or Plaque, Device Embedded In
3
3
Arrhythmia
3
3
Exposure to Body Fluids
3
3
Bradycardia
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Thrombosis/Thrombus
2
2
Cardiac Arrest
2
2
Embolism
2
2
Hematoma
2
2
Ischemia
2
2
Muscle Spasm(s)
2
2
Thrombus
2
2
Tissue Damage
2
2
Pain
2
2
Ventricular Fibrillation
2
2
Cardiac Tamponade
2
2
Obstruction/Occlusion
2
2
Perforation
2
2
ST Segment Elevation
2
2
Not Applicable
2
2
Full thickness (Third Degree) Burn
2
2
Ischemia Stroke
1
1
Tics/Tremor
1
1
Embolism/Embolus
1
1
Hypervolemia
1
1
Superficial (First Degree) Burn
1
1
Skin Inflammation
1
1
Low Oxygen Saturation
1
1
Cardiac Perforation
1
1
Burn, Thermal
1
1
Cognitive Changes
1
1
Vascular System (Circulation), Impaired
1
1
Cardiogenic Shock
1
1
Stenosis
1
1
Perforation of Vessels
1
1
Dizziness
1
1
Electrolyte Imbalance
1
1
Paralysis
1
1
Hepatitis
1
1
Transient Ischemic Attack
1
1
Muscle Weakness
1
1
Myocardial Infarction
1
1
Overdose
1
1
Memory Loss/Impairment
1
1
Edema
1
1
Infarction, Cerebral
1
1
Cyanosis
1
1
Atrial Fibrillation
1
1
Bacterial Infection
1
1
Angina
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edward Lifesciences, Llc
II
Sep-16-2015
2
Edwards Lifesciences, LLC
II
Jun-25-2021
3
Edwards Lifesciences, LLC
II
Dec-17-2015
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